safety and performance of a hernia blocking system

Conditions: Disk Herniated Lumbar

Summary: prospective, multi-center, single-arm clinical study to assess the performance of an hernia blocking system in preventing clinically symptomatic recurrent lumbar disc herniation.


Eligibility criteria:
inclusion criteria: * subject is between 18 and 75 years of age. * posterolateral disc herniation at one level between l4 and s1 with radiographic confirmation (ct and/or mri) of neural compression. * at least six weeks of failed conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage and/or administration of epidural/facet injections. * minimum posterior disc height of 5 mm at the index level. * radiculopathy with positive straight leg raise test. * odi score of at least 40/100. * subjects who are able to give voluntary informed consent to participate in the clinical investigation and from whom consent has been obtained. * subject is able and willing to comply with the protocol requirements. exclusion criteria: * spondylolisthesis and/or instability at the index level. * foraminal, extra-foraminal or central disc herniation. * subject has clinically compromised vertebral bodies in the lumbosacral region due to any traumatic, neoplastic, metabolic, or infectious pathology. * subject has scoliosis of greater than 20 degrees (both angular and rotational). * less than 20 mm of interpedicular distance in the spinal canal at the index level. * grossly distorted anatomy due to congenital abnormalities. * deformation that affect the posterior corners of the vertebra at the index level (e.g., osteophytes). * endplate irregularities that, in the judgment of the surgeon, could affect the device implantation. * prior surgery at the index lumbar vertebral level. * radiological confirmation of severe facet joint disease or degeneration. * patients diagnosed or at a high risk of osteoporosis (such as postmenopausal women and patients receiving long-term treatment with corticosteroids) who present a bone densitometry dxa t-score of less than -2.0 at the index level. * cauda equina syndrome. * fever, leucocytosis and/or systemic or localized active infection. * systemic inflammation and/or inflammation at the implantation site. * any metabolic bone disease. * insulin-dependent diabetes mellitus. * peripheral neuropathy. * active hepatitis, aids or hiv. * rheumatoid arthritis or other autoimmune disease. * active or history of any invasive malignancy; patients with curatively-treated malignancies who have been disease-free for at least 5 years are eligible. * active tuberculosis or history of tuberculosis in the past 3 years. * immunologically suppressed patients. * current anticoagulation therapy, unless anticoagulation therapy can be suspended for surgery. * patients who have received medication (e.g., methotrexate, alendronate) that interferes with bone mineral metabolism within 4 weeks of the planned date of the index surgery. * suspected or known allergies or intolerance to the implant materials. * any condition that precludes the use of general anesthesia. * any condition that precludes the surgical procedure. * any contraindication for mri or ct scan. * class iii obesity: body mass index ≥ 40. * current alcohol or recreational drug dependency. * pregnant or interested in becoming pregnant in the following 24 months. * breastfeeding. * life expectancy less than 2 years. * subject is currently participating or has participated in the previous 4 weeks in any other interventional clinical study.